August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.

May 30, 2013 (NOT-OD-13-074) -
NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

People with severe mental illness (SMI) die from the same
causes as those in the general population, e.g., heart disease, diabetes,
cancer, stroke, and pulmonary disease. However, these diseases are more
common in people with SMI and lead to earlier death. The modifiable health
risk factors that contribute to these diseases—smoking, obesity,
hypertension, metabolic disorder, substance use, low physical activity, poor
fitness and diet—are also more common and have an earlier onset in people
with SMI. Side effects of psychiatric medications, which may include weight
gain and metabolic disorder, add to these health risks. Effective
interventions to reduce these common modifiable health risk factors exist for
the general population, however, they are generally unavailable to people
with SMI and evidence is sparse on how to bring them to this population. This
FOA will support R01 grants of up to five years for rigorous effectiveness
testing of innovative services interventions designed to reduce the
prevalence and magnitude of common modifiable health risk factors related to
shortened lifespan in adults with severe mental illness (SMI), as well as in
children and youth with serious emotional disturbances (SED).

Key Dates

Posted Date

March 12, 2013

Open Date (Earliest Submission Date)

October 7, 2013

Letter of Intent Due Date(s)

October 7, 2013

Application Due Date(s)

November 7, 2013, by 5:00 PM local time of applicant
organization.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February 2014

Advisory Council Review

May 2014

Earliest Start Date

July 2014

Expiration Date

November 8, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all requirements (both
in the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

People with severe mental illness (SMI) die from the same
causes as those in the general population, e.g., heart disease, diabetes,
cancer, stroke, and pulmonary disease. However, these diseases are more common
in people with SMI and lead to earlier death. For example, adults with
psychotic disorders die, on average, 11 years earlier than adults with no
mental disorder, most often from these co-morbid medical conditions (Druss,
Zhao, Von Esenwein, Morrato & Marcus, 2011). The modifiable health risk
factors that contribute to these diseases—smoking, obesity, hypertension,
metabolic disorder, low physical activity, substance use, poor fitness and
diet—are also more common and have an earlier onset in people with SMI (SAMHSA,
2008-2010). Two-thirds or more of adults with SMI smoke (Goff, Sullivan,
McEvoy, Meyer, Nasrallah, Daumit,et al., 2005); over 40% are obese, 60% for
women (Allison, Fontaine, Heo, Chandler, Capelleri, Infante, et al., 1999;
McElroy, 2002); and metabolic syndrome is highly prevalent, especially in women
(McEvoy, Meyer, Goff, Nasrallah, Davis, Sullivan, et al., 2005). Iatrogenic
effects of psychiatric medications, which may include weight gain and metabolic
disorder, add to these health risks (Allison, Mentore, Heo, et al., 1999). The
11.4 million adults with SMI in the U.S. are disproportionately affected by
these modifiable health risk factors, and their low rates of prevention,
detection, and treatment result in substantial disease burden and premature
mortality (Druss et al., 2011; Nasrallah, Meyer, Goff, et al., 2006; SAMHSA,
2008-2010). Effective interventions to reduce these health risk factors exist
for the general population, but they are generally unavailable to people with
SMI. Furthermore, the impact of these interventions and the degree of
adaptation needed for effectiveness in people with SMI, who may experience
cognitive impairment, motivational deficits, challenges in functioning, social
isolation, poverty, and limited access to healthcare, remain unknown.

The initial occurrence and early progression of modifiable
health risk factors associated with premature mortality are poorly understood,
but at least some of the increased risk that compromises health and longevity
begins to emerge prior to adulthood. Children and adolescents may be especially
vulnerable to the adverse metabolic effects of psychiatric medications given
their developing bodies and brains (De Hert, Detraux, van Winkel, et al.,
2012). Moreover, the number of children and adolescents prescribed psychiatric
medications—for both off-label and FDA-approved uses—is growing, which may
increase the number of young people developing modifiable health risk factors
associated with premature mortality as well as lead to earlier onset of these
risk factors (Comer, Olfson & Mojtabai, 2010).

In September of 2012, NIMH hosted a meeting, Research to Improve Health and
Longevity of People with Severe Mental Illness, which brought
together leading researchers, state administrators who have implemented
programs to reduce modifiable health risk factors in people with SMI, advocates
for this population, policy leaders and representatives from other NIH
institutes and federal agencies. Key research priorities that emerged from this
two-day meeting include the following:

Studies targeting medical comorbidities, tobacco cessation,
prevention of diabetes and cardiovascular disease, and reduction in
psychotropic polypharmacy as the major intervention targets to reduce premature
mortality;

Studies that leverage existing “natural experiments” by testing
the effectiveness of promising services interventions already implemented at
state and local levels;

Studies integrating a combination of interventions that are often
harder to sustain but produce more robust effects compared to the modest
effects of single component interventions;

Studies that improve our understanding of how best to integrate
multiple treatment components; and

Studies to develop and test strategies that reduce or eliminate
racial, ethnic or gender disparities in the development of medical
comorbidities, or in the receipt of or response to interventions addressing
comorbidities among people with SMI.

Nature of the Funding Opportunity

The goal of this Funding Opportunity Announcement (FOA) is
to support research to test the effectiveness of services interventions that
specifically target adults with SMI and aim to reduce the prevalence and
magnitude of common modifiable health risk factors that contribute to premature
mortality in this population, using the most rigorous methods possible. This
FOA is also intended to support research for children and youth with serious
emotional disturbances (SED) in order to target common modifiable health risk
factors at an early stage in the developmental process. (For purposes of this
FOA, NIMH defines “severe mental illness” or SMI and “serious emotional
disturbance” or SED as a diagnosable psychiatric disorder that results in
functional impairment which substantially interferes with or limits major life
activities. The criteria for inclusion as an SMI or SED relate to the severity
of the psychiatric disorder causing significant impairment rather than to a
specific diagnostic category, per se.)

This initiative will support research that builds on
strategies proven effective in reducing modifiable health risk factors in the
general population. Applications that develop and test service interventions
for large-scale delivery of these effective strategies to people with SMI or
SED are encouraged. To that end, critical aspects of the intervention and
delivery strategy should be designed so as to support broad dissemination and
implementation of the approach should it prove effective. The research
generated should address at least one of the following questions:

1. How can strategies proven effective for reducing
common modifiable health risk factors in the general population be adapted with
the goal of achieving equivalent effectiveness for people with SMI or SED?

2. How can capacity to deliver needed health risk
prevention and reduction be significantly improved to reach the largest number
of people with SMI or SED?

Examples of research questions considered responsive to this
FOA include, but are not limited to, the following:

How can a diabetes prevention program, effective in the general
population, produce the same health benefits in people with SMI or SED?

How can medication management approaches minimize the adverse
health consequences of antipsychotic medication while maintaining optimal
psychiatric and functional outcomes in adults with SMI? In children and youth
with SED?

How can community mental health centers efficiently incorporate
clinical decision support tools to maximize screening and engagement in care
for modifiable health risk factors associated with cardiovascular disease?

Can the targeted use of social media support smoking cessation in
adults with SMI?

What strategies enable non-health care settings to serve as
effective platforms for detection of common modifiable health risk factors and
linkage to treatment?

Can a smartphone application targeting fitness, diet and obesity
produce clinically significant outcomes in this population?

What strategies can reduce or eliminate racial, ethnic or gender
disparities among people with SMI in the development of medical comorbidities
or the receipt of or response to treatment for these comorbidities?

In addition, NIMH encourages applicants to also consider
factors influencing implementation of the services intervention that is the focus
of the research project. Services interventions with health promotion,
lifestyle change and self-management components for people with SMI are
encouraged, as well as those integrating intervention components in order to
target multiple health risk factors and/or increase the magnitude of treatment
effects. Examples of services interventions for people with SMI or SED might
include, but are not limited to, those involving one or more of the following:

The services intervention must specifically target people
with SMI or SED and modifiable health risk factors that are the primary causes
of premature mortality in this population. Ideally, the services intervention
will have the following features:

has demonstrated clinical effectiveness of the intervention's
core components in the general population (although adaption may be needed for
equivalent effectiveness in people with SMI or SED);

has relevance to the life circumstances of people with SMI or
SED;

will be conducted in a community-based setting that serves as a
platform to engage this population (either within or outside of traditional
healthcare settings);

has the potential to produce clinically (not just statistically)
significant health improvement and reduction in common modifiable health risk
factors associated with early mortality in people with SMI;

will target all people with SMI or SED in a given setting,
community or care delivery system;

has a high likelihood for real-world feasibility in terms of
required resources, staffing, training, and patient acceptability;

has strong potential to be expanded easily to many settings, so
as to reach a large portion of people with SMI or SED at risk, should the
services intervention prove clinically effective with this population.

A variety of rigorous methodological approaches are possible
for testing the impact of the services intervention. These approaches include
randomized controlled trials, quasi-experimental designs with non-randomized
comparison groups, time series designs, and other designs of equivalent rigor
and relevance. Considerations for selecting a research design for the proposed
effectiveness study include the scientific question that the study is designed
to answer, practical constraints, ethical issues, and the tradeoff between
maximizing internal and external validity. The applicant should explain how the
selected research methods minimize confounds that may limit the ability to
infer causality. Regardless of the proposed methods, the project should include
assessment of clinically significant patient-level outcomes that represent
objective indicators of health improvement, e.g., improved glycemic levels,
improved lipid levels, lowered cholesterol levels, healthier body mass index,
and lowered blood pressure.

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should
work with their organizational officials to either create a new account or to
affiliate an existing account with the applicant organization’s eRA Commons
account. If the PD/PI is also the organizational Signing Official, they must
have two distinct eRA Commons accounts, one for each role. Obtaining an eRA
Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the NIH
Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all
applicable components, required and optional. Please note that some
components marked optional in the application package are required for
submission of applications for this FOA. Follow all instructions in the SF424
(R&R) Application Guide to ensure you complete all appropriate “optional”
components.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide
must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Cover Letter

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the due date to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the
status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the application
due date. If a Changed/Corrected application is submitted after the deadline,
the application will be considered late.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD(s)/PI(s) must include their eRA Commons ID in the
Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH. See Section III of this FOA for information on
registration requirements.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management. Additional information may be
found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and responsiveness by NIMH, NIH. Applications that are
incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to
notify the NIMH Referral Office by email at NIMHReferral@mail.nih.gov when the
application has been submitted. Please include the FOA number and title, PD/PI
name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field? Is evidence provided that supports the potential of the proposed services intervention to produce clinically
meaningful (versus statistically significant) reductions in common modifiable
health risk factors associated with premature mortality in the target
population of people with SMI or SED? Is the proposed services intervention
designed to support broad dissemination and implementation in real-world
settings should it prove effective? Does the application address a critical
question related to (1) adapting evidence-based health risk reduction
interventions to achieve clinically significant effectiveness in people with
for SMI or SED, or (2) increasing capacity to deliver health risk reduction
interventions to populations with SMI or SED? If the services intervention
targets a population with multiple health risk factors, does it integrate the
multiple components of the intervention?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD/PI, do the investigators have complementary
and integrated expertise; are their leadership approach, governance and
organizational structure appropriate for the project? Do the qualifications of the PD/PI and other senior investigators include expertise in one
or more of the following areas:

Implementing
health promotion or risk reduction programs for people with SMI or SED;

Recruiting
and retaining people with SMI or SED in large-scale studies; and

Assessing
common modifiable health risk factors?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed? Does the proposed services intervention use novel means to increase the intervention's
effectiveness, efficiency or reach to people with SMI or SED?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed? Do the chosen outcome variables represent relevant and objective measures of health
improvement, such as improved glycemic levels, improved lipid levels, lowered
cholesterol levels, healthier body mass index, and lowered blood pressure?
Where applicable, does the application adequately address racial, ethnic, or
gender disparities in the receipt of or response to health risk reduction
interventions among people with SMI or SED? Has the applicant explained how the
selected research methods minimize confounds that may limit the ability to
infer causality?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements? Does the proposed services intervention capitalize on a
real-world setting that is already engaging people with SMI or SED?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), convened by the NIMH, in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in
response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds
with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a
second level of review by the National Advisory Mental Health Council. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

When multiple years are involved, awardees will be required
to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR)
and financial statements as required in the NIH
Grants Policy Statement.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.